]>
IRCT20150915024031N2 IRCT 2021-03-17 Tehran University of Medical Sciences "Effect of therapeutic ultrasound on chronic rhino sinusitis" Effect of therapeutic pulsed ultrasound on severity of symptoms of patients with chronic rhino-sinusitis with and without polyposis- A randomized clinical trial 2021-04-21 anticipated 44 Complete https://irct.ir/trial/53822 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on the role of random allocation. In this method, 22 letters A representing the intervention group and 22 letters B representing the control group are placed in a container. Then a letter is accidentally removed from the container. If the letter A is, the person goes to the intervention group and if it is the letter B, the person goes to the control group. Similarly, we divide 44 people into 2 random groups, Blinding description: Patients participating in this study are blind. At the beginning of treatment, patients in the control group are not treated with ultrasound and only the ultrasound light is on as visual feedback. And the same light is on in the intervention group, and neither group is aware of the device output. N/A Chronic rhino sinusitis. Intervention 1: The intervention group receives ,the Japanese ITO-750 model, 3 days a week with ultrasound therapy in the maxillary and frontal sinuses. The frequency and intensity used for each frontal sinus is 3 MHz and 0.5 watts per square centimeter and for each maxillary sinus is 1 MHz and 1 watt per square centimeter. The total treatment time is 18 minutes, which is 4 minutes for each frontal sinus and 5 minutes for each maxillary sinus. MHz and 1 watt per square centimeter for each maxillary sinus. The total treatment time is 18 minutes, which is 4 minutes for each frontal sinus and 5 minutes for each maxillary sinus. Intervention 2: Control group: Participants in the control group who, like the intervention group, have chronic sinusitis. The procedure is relatively similar to that of the intervention group, with the same device as the ITO-750 model made in Japan, and they receive physical treatment three days a week. The difference is that in this group, no ultrasound waves are emitted through the device, but they are told that the bright light of the device indicates the penetration of waves in the body. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet - the release schedule is unknown
public Mojtaba Mohammadi Ardehali
Keshavarz BLV, Ghods street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 3698 8163 mohamadm@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mojtaba Mohammadi Ardehali
Keshavarz Blv, Ghods Street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 3698 8163 mohamadm@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) No malignant tumor on the head and face Has comprehensible literacy and verbal power Ability to recognize and comprehend at the natural level 20 years 50 years Both Having cold during treatment Acute recurrence of rhinosinusitis J32 Chronic sinusitis Rehabilitation Rehabilitation The intervention group receives ,the Japanese ITO-750 model, 3 days a week with ultrasound therapy in the maxillary and frontal sinuses. The frequency and intensity used for each frontal sinus is 3 MHz and 0.5 watts per square centimeter and for each maxillary sinus is 1 MHz and 1 watt per square centimeter. The total treatment time is 18 minutes, which is 4 minutes for each frontal sinus and 5 minutes for each maxillary sinus. MHz and 1 watt per square centimeter for each maxillary sinus. The total treatment time is 18 minutes, which is 4 minutes for each frontal sinus and 5 minutes for each maxillary sinus. Control group: Participants in the control group who, like the intervention group, have chronic sinusitis. The procedure is relatively similar to that of the intervention group, with the same device as the ITO-750 model made in Japan, and they receive physical treatment three days a week. The difference is that in this group, no ultrasound waves are emitted through the device, but they are told that the bright light of the device indicates the penetration of waves in the body. Score in 20 item questionnaire SinoNasal outcome Test-20 (SNOT-20). Timepoint: first and second session. Method of measurement: SNOT-20 questioner. Lund Kennedy endoscopic scale. Timepoint: First and last session. Method of measurement: Lund Kennedy endoscopic scale. Lund Mackay scale. Timepoint: First and last session. Method of measurement: Lund Mackay scale. Tehran University of Medical Sciences Approved 2020-11-09 Ethics committee of Tehran university of medical sciences Keshavarz Blvd., Ghods St., Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)